For Immediate Release

August 23, 2018

Release

The U.S. Food and Drug Administration today announced that all 17 manufacturers, distributors and retailers that were warned by the agency in May, have stopped selling the nicotine-containing e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products, such as juice boxes, candy or cookies that were identified through warning letters as being false or misleading. The warning letters – many in partnership with the Federal Trade Commission – are part of ongoing efforts to protect youth from the dangers of nicotine and tobacco products. Several of the companies that received warning letters had also been cited for illegally selling the products to minors.

“Removing these products from the market was a critical step toward protecting our kids. We can all agree no kid should ever start using any tobacco or nicotine-containing product, and companies that sell them have a responsibility to ensure they aren’t enticing youth use. When companies market these products using imagery that misleads a child into thinking they’re things they’ve consumed before, like a juice box or candy, that can create an imminent risk of harm to a child who may confuse the product for something safe and familiar,” said FDA Commissioner Scott Gottlieb, M.D. “Even as we encourage the innovation of novel and potentially less harmful products such as e-cigarettes for currently addicted adult smokers, we’re committed to holding industry accountable to ensure these products aren’t being marketed to, sold to, or used by kids. The FDA will continue to take vigorous actions under our Youth Tobacco Prevention Plan to restrict youth access, limit youth appeal, and reduce toxic exposure to youth from all tobacco products, and, in particular, e-cigarettes. We expect to take additional, robust enforcement actions over the next few months that target those who we believe are allowing these products to get into the hands of children.”

Some examples of the products outlined in the warning letters included: “One Mad Hit Juice Box,” which resembled children’s apple juice boxes, such as Tree Top-brand juice boxes; “Whip’d Strawberry,” which resembled Reddi-wip dairy whipped topping; “Twirly Pop,” which not only resembled a Unicorn Pop lollipop but was shipped with one; and “Unicorn Cakes,” which included images and cartoons of pancakes, a strawberry beverage and unicorns eating pancakes, similar to graphics and images from the “My Little Pony” television and toy franchise.

Following the warning letters in May, the FDA worked to ensure the companies took appropriate corrective action – such as no longer selling the products with the misleading labeling or advertising – and issued close-out letters to the firms. The agency expects some of the companies may sell the products with revised labeling that addresses the concerns expressed in the warning letters. The FDA will continue to monitor tobacco product labeling and advertising for potential violations of the law and act as appropriate.

The warning letters stemmed from investigations that began in late 2017 of tobacco product labeling and advertising that imitated food products, particularly those that are marketed toward, and/or appealing to, children. The products were considered misbranded and sold in violation of the Federal Food, Drug, and Cosmetic Act because their labeling and/or advertising imitating kid-friendly foods was misleading. The FTC joined the FDA on 13 of the warning letters under Section 5 of the Federal Trade Commission Act, which prohibits unfair or deceptive advertising.

“The fact that these companies have stopped their dangerous and deceptive tactics to attract kids to their vaping products is a timely, positive and appropriate action,” said FTC Chairman Joe Simons. “The FTC’s message is direct and consistent: We are watching, and we will take action immediately when deception places kids at risk.”

The continuing rise in popularity of electronic nicotine delivery systems (ENDS), such as e-cigarettes, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to e-liquid poisoning and other liquid nicotine exposure of children younger than six, according to a recent analysis of National Poison Data System data. Severe harm can occur in small children from exposure to or ingestion of e-liquids, including death from cardiac arrest, as well as seizure, coma and respiratory arrest.

Additionally, more than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016, with flavor availability being one of the top reasons for use. This use by children and teens is especially concerning to the FDA because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future. That’s why combating youth use of nicotine-containing products is a core priority and the guiding principle behind the FDA’s Youth Tobacco Prevention Plan. In April, for example, the agency conducted a nationwide blitz of brick-and-mortar and online retailers, and issued warning letters to businesses that sold JUUL brand products to minors. The agency also sent letters to JUUL Labs and several other companies requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of these products. The FDA is also continuing its enforcement efforts to reduce tobacco product sales to minors.

As part of the FDA’s comprehensive plan on nicotine and tobacco regulation announced last summer, the agency is also exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth. This could include measures on flavors/designs that appeal to youth, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine. The FDA also issued an advance notice of proposed rulemaking in March to seek public comment on the role that flavors in tobacco products play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. The FDA has also expanded “The Real Cost” public education campaign with messages focused on preventing youth use of e-cigarettes and will launch a full-scale campaign in September.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.